Principal Enterprise Business Architect (Biotech)
Stemline Therapeutics, Inc., New York, NY, United States
Overview
Principal Enterprise Business Architect (Biotech)
Reports to Global Head of Information Technology, Oncology
Opportunity
As a seasoned Enterprise Business Architect, you'll be the master weaver connecting our scientific breakthroughs to our global commercial strategy. In the fast-paced world of biotechnology, where R&D cycles are long and regulatory landscapes are shifting, your role is to ensure our operating model is agile, scalable, and data-driven. As our Principal Enterprise Business Architect, you will be the primary architect of a "Digital-First" biotech operating model. Your mission is to integrate Artificial Intelligence (AI) into the core of the pharma value chain-transforming how we execute clinical trials and bring our medicines to market for patients.
You will act as the bridge between Executive Leadership, Stemline business functions, and IT, ensuring that every investment we make moves the needle on our mission to deliver life-saving therapies.
Responsibilities
Strategic Alignment:
Translate corporate strategy (e.g., "Accelerate Phase III trials" or "transform Oncology business") into actionable business capabilities and roadmaps. Operating Model Design:
Define and evolve the enterprise business architecture, ensuring that our processes-from drug development to commercial launch-are integrated and efficient. Capability Mapping:
Maintain the enterprise business capability map for the Menarini Stemline Oncology business, identifying gaps, redundancies, and opportunities for digital transformation. Cross-Functional Orchestration:
Partner with the business to ensure technology stacks (CTMS, EDC, ERP) support the actual needs of the business. Governance & Standards : Establish and lead a Business Architecture Guild to ensure consistency in how processes are documented and improved across the organization. Partner with Corporate IT, Legal, Compliance and Data Privacy business functions to establish the enterprise framework for Responsible AI, ensuring that model transparency, data privacy (GDPR/HIPAA) are managed across all business units. Investment Advisory and IT execution oversight:
Provide architectural oversight for large-scale capital investments, ensuring "Project A" doesn't break "Process B." Qualifications
Experience : 15+ years in Enterprise Architecture or Strategic Business Consulting, with at least 10 years specifically within Life Sciences, Biotech, or Pharma (required). Domain Expertise:
Deep understanding of the Value Chain in Biotech: Pre-clinical, Clinical Trials (GCP), Regulatory Affairs, and Market Access. Technical Fluency:
While this isn't a coding role, you must be comfortable discussing Cloud Strategy, Data Lakes, and AI/ML applications in drug discovery. Framework Mastery:
Expert-level knowledge of TOGAF, BizBOK, or similar frameworks, adapted for an agile environment. AI/ML Strategy:
Proven experience architecturalizing AI use cases within a GxP-regulated environment. You understand the difference between a "pilot project" and an Agentic AI workflow that can reason and act within a business process. Data Architecture for AI:
Understanding of Data Fabric and Data Mesh concepts to ensure that high-quality, "AI-ready" data is available across the enterprise. Ecosystem Partnerships : Experience managing a portfolio of partnerships with "AI-first" biotech startups and cloud-based HPC providers (e.g., NVIDIA, Google Cloud Life Sciences).
Please note: this position is classified as a corporate office position. In accordance with the New York employer convenience rule, Stemline will withhold New York state income taxes for all corporate office employees, regardless of whether these employees work in New York or remotely.
Base Salary Range of $190,000 - $240,000. Menarini Stemline offers generous compensation and benefits packages, including Short- and Long-Term Incentive Programs, Fidelity 401(k) (with company match), Anthem Premier PPO and HDHP insurance plans, Company paid Basic Life & AD&D insurance and pre-tax FSA/HSA programs.
Menarini Stemline is committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions.
The Company
Founded in 1886 in Naples under the name of Farmacia Internazionale, Menarini moved in 1915 to Florence where the Group's headquarters are still located today. High quality therapeutics and diagnostics solutions for patients, ethics as our underlying principle, dedication to innovation and advancement, strong people centricity and environmental sustainability. These five pillars form the foundation of the Menarini Group, an Italian pharmaceutical company with nearly 135 years of history.
The Menarini Group is present in 70 countries and our products are sold in 140 locations around the world. Its companies span from Europe to Asia, to Africa and the Middle East, to Central America and to the United States where with the acquisition of Stemline Therapeutics, a NASDAQ-listed biopharmaceutical company, the company marked its entry into the US oncology market.
Thanks to the valuable contribution of around 18,000 employees, every year more than 500 million packs of drugs are produced at the Group's 18 manufacturing sites including a biotech plant for the manufacturing of monoclonal antibodies that also serves external clients distributed across 6 continents.
Menarini has made a strong commitment to oncology, investing in a pipeline of five investigational compounds for the treatment of a variety of haematological and solid tumours. The acquisition of Stemline Therapeutics in June 2020, further strengthened Menarini's oncology portfolio, adding both commercial and clinical-stage assets. Tagraxofusp is a novel, first in class targeted therapy for patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN) and to date, the only approved treatment for BPDCN in the U.S. and EU, and the first and only approved CD123-targeted therapy. Tagraxofusp is also being evaluated as both a single agent and in combination, in other CD123+ indications, including acute myeloid leukaemia (AML), chronic myelomonocytic leukaemia (CMML), and myelofibrosis (MF).
Additionally, Menarini received exclusive rights to commercialise Selinexor for the treatment of oncology indications in the European Union and other European countries (including the United Kingdom), Latin America and other key countries. Menarini has signed an exclusive licensing agreement with Karyopharm Therapeutics for the rights to commercialise an innovative therapeutic option in Europe, Latin America, Turkey, Russia, and CIS countries. Selinexor is a first-in-class, oral Selective Inhibitor of Nuclear export compound for the treatment of hematologic cancers and solid tumours. It is already marketed in the US for multiple myeloma and is under development for solid tumour indications. Selinexor is registered in the EU for both early and late lines.
Menarini entered into a global licence agreement with Radius Health to complete the development of Elacestrant, an oral SERD in late-stage Phase 3 development for hormone receptor-positive advanced breast cancer. Following a successful phase 3 study, Menarini Stemline received FDA approval in January 2023 under priority review and successfully oversaw a strong launch in February to the US market with the EMA review process concluded positively in September 2023.
It is an exciting time in the company's development and an excellent opportunity for individuals joining us to contribute to building and shaping Menarini Stemline's Oncology business.
Principal Enterprise Business Architect (Biotech)
Reports to Global Head of Information Technology, Oncology
Opportunity
As a seasoned Enterprise Business Architect, you'll be the master weaver connecting our scientific breakthroughs to our global commercial strategy. In the fast-paced world of biotechnology, where R&D cycles are long and regulatory landscapes are shifting, your role is to ensure our operating model is agile, scalable, and data-driven. As our Principal Enterprise Business Architect, you will be the primary architect of a "Digital-First" biotech operating model. Your mission is to integrate Artificial Intelligence (AI) into the core of the pharma value chain-transforming how we execute clinical trials and bring our medicines to market for patients.
You will act as the bridge between Executive Leadership, Stemline business functions, and IT, ensuring that every investment we make moves the needle on our mission to deliver life-saving therapies.
Responsibilities
Strategic Alignment:
Translate corporate strategy (e.g., "Accelerate Phase III trials" or "transform Oncology business") into actionable business capabilities and roadmaps. Operating Model Design:
Define and evolve the enterprise business architecture, ensuring that our processes-from drug development to commercial launch-are integrated and efficient. Capability Mapping:
Maintain the enterprise business capability map for the Menarini Stemline Oncology business, identifying gaps, redundancies, and opportunities for digital transformation. Cross-Functional Orchestration:
Partner with the business to ensure technology stacks (CTMS, EDC, ERP) support the actual needs of the business. Governance & Standards : Establish and lead a Business Architecture Guild to ensure consistency in how processes are documented and improved across the organization. Partner with Corporate IT, Legal, Compliance and Data Privacy business functions to establish the enterprise framework for Responsible AI, ensuring that model transparency, data privacy (GDPR/HIPAA) are managed across all business units. Investment Advisory and IT execution oversight:
Provide architectural oversight for large-scale capital investments, ensuring "Project A" doesn't break "Process B." Qualifications
Experience : 15+ years in Enterprise Architecture or Strategic Business Consulting, with at least 10 years specifically within Life Sciences, Biotech, or Pharma (required). Domain Expertise:
Deep understanding of the Value Chain in Biotech: Pre-clinical, Clinical Trials (GCP), Regulatory Affairs, and Market Access. Technical Fluency:
While this isn't a coding role, you must be comfortable discussing Cloud Strategy, Data Lakes, and AI/ML applications in drug discovery. Framework Mastery:
Expert-level knowledge of TOGAF, BizBOK, or similar frameworks, adapted for an agile environment. AI/ML Strategy:
Proven experience architecturalizing AI use cases within a GxP-regulated environment. You understand the difference between a "pilot project" and an Agentic AI workflow that can reason and act within a business process. Data Architecture for AI:
Understanding of Data Fabric and Data Mesh concepts to ensure that high-quality, "AI-ready" data is available across the enterprise. Ecosystem Partnerships : Experience managing a portfolio of partnerships with "AI-first" biotech startups and cloud-based HPC providers (e.g., NVIDIA, Google Cloud Life Sciences).
Please note: this position is classified as a corporate office position. In accordance with the New York employer convenience rule, Stemline will withhold New York state income taxes for all corporate office employees, regardless of whether these employees work in New York or remotely.
Base Salary Range of $190,000 - $240,000. Menarini Stemline offers generous compensation and benefits packages, including Short- and Long-Term Incentive Programs, Fidelity 401(k) (with company match), Anthem Premier PPO and HDHP insurance plans, Company paid Basic Life & AD&D insurance and pre-tax FSA/HSA programs.
Menarini Stemline is committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions.
The Company
Founded in 1886 in Naples under the name of Farmacia Internazionale, Menarini moved in 1915 to Florence where the Group's headquarters are still located today. High quality therapeutics and diagnostics solutions for patients, ethics as our underlying principle, dedication to innovation and advancement, strong people centricity and environmental sustainability. These five pillars form the foundation of the Menarini Group, an Italian pharmaceutical company with nearly 135 years of history.
The Menarini Group is present in 70 countries and our products are sold in 140 locations around the world. Its companies span from Europe to Asia, to Africa and the Middle East, to Central America and to the United States where with the acquisition of Stemline Therapeutics, a NASDAQ-listed biopharmaceutical company, the company marked its entry into the US oncology market.
Thanks to the valuable contribution of around 18,000 employees, every year more than 500 million packs of drugs are produced at the Group's 18 manufacturing sites including a biotech plant for the manufacturing of monoclonal antibodies that also serves external clients distributed across 6 continents.
Menarini has made a strong commitment to oncology, investing in a pipeline of five investigational compounds for the treatment of a variety of haematological and solid tumours. The acquisition of Stemline Therapeutics in June 2020, further strengthened Menarini's oncology portfolio, adding both commercial and clinical-stage assets. Tagraxofusp is a novel, first in class targeted therapy for patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN) and to date, the only approved treatment for BPDCN in the U.S. and EU, and the first and only approved CD123-targeted therapy. Tagraxofusp is also being evaluated as both a single agent and in combination, in other CD123+ indications, including acute myeloid leukaemia (AML), chronic myelomonocytic leukaemia (CMML), and myelofibrosis (MF).
Additionally, Menarini received exclusive rights to commercialise Selinexor for the treatment of oncology indications in the European Union and other European countries (including the United Kingdom), Latin America and other key countries. Menarini has signed an exclusive licensing agreement with Karyopharm Therapeutics for the rights to commercialise an innovative therapeutic option in Europe, Latin America, Turkey, Russia, and CIS countries. Selinexor is a first-in-class, oral Selective Inhibitor of Nuclear export compound for the treatment of hematologic cancers and solid tumours. It is already marketed in the US for multiple myeloma and is under development for solid tumour indications. Selinexor is registered in the EU for both early and late lines.
Menarini entered into a global licence agreement with Radius Health to complete the development of Elacestrant, an oral SERD in late-stage Phase 3 development for hormone receptor-positive advanced breast cancer. Following a successful phase 3 study, Menarini Stemline received FDA approval in January 2023 under priority review and successfully oversaw a strong launch in February to the US market with the EMA review process concluded positively in September 2023.
It is an exciting time in the company's development and an excellent opportunity for individuals joining us to contribute to building and shaping Menarini Stemline's Oncology business.